Human Papillomavirus (HPV) Vaccine
Vaccine Information Statement (VIS) - Human Papillomavirus (HPV) Vaccine
February 24, 2012 -- On February 22, 2012, a new Vaccine Information Statement (Interim) was posted for the Human Papillomavirus (HPV) vaccine, Gardasil®. Please note that the VIS for the other HPV vaccine, Cervarix®, is unchanged. The main purpose for changing the VIS for Gardasil® is to incorporate the Advisory Committee on Immunization Practice's (ACIP) decision to recommend the vaccine routinely for adolescent males. Because using the previous VIS could cause confusion about this recommendation, we recommend beginning to use the new VIS as soon as possible.
VIS are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VIS be handed out when (before each dose) certain vaccinations are given.
This updated VIS has been integrated into the Florida SHOTS (Florida State Health Online Tracking System), so registry users can access them electronically.
Healthcare providers should periodically access the VIS electronically and print out a supply for routine distribution. If necessary, bureau staff can FAX copies to providers without internet access.
Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males
January 6, 2012 -- In the December 23, 2011, Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention published Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males — Advisory Committee on Immunization Practices (ACIP), 2011.
On October 25, 2011, the ACIP recommended routine use of quadrivalent human papillomavirus (HPV) vaccine (HPV4; Gardasil®, Merck & Co. Inc.) in males 11 or 12 years of age. The ACIP also recommended vaccination with HPV4 for males 13 through 21 years of age who have not been vaccinated previously or who have not completed the 3-dose series; males 22 through 26 years of age may be vaccinated. These recommendations replace the October 2009 ACIP guidance that HPV4 may be given to males 9 through 26 years of age. For these recommendations, the ACIP considered information on vaccine efficacy (including data available since October 2009, on prevention of grade 2 or 3 anal intraepithelial neoplasia [AIN2/3], a precursor of anal cancer), vaccine safety, estimates of disease and cancer resulting from HPV, cost-effectiveness, and programmatic considerations.
The release discusses the rationale behind changing the recommendation for a vaccine that may be given to that of a vaccine that should be given. You will also find additional information regarding recommendations to special populations (immunocompromised, HIV positive persons, MSM, etc.) The burden of disease and cancer in males, efficacy, and safety of the vaccine are also presented.
We encourage your review of these recommendations. The vaccine information statements for HPV are also availabe and translations are avalable at the Immunization Action Coalition web site.
Human Papillomavirus (HPV4) Approved for 11-12 Year Old Males
October 31, 2011 -- On October 25, 2011, the Centers for Disease Control and Prevention (CDC) held a media conference regarding the Advisory Committee on Immunization Practices (ACIP) vote to recommend that all 11-12 year-old males get vaccinated against HPV.
ACIP Provisional Recommendations for Human Papillomavirus Vaccine
April 4, 2010 -- On October 21, 2009, the ACIP voted to approve updated recommendations for use of Human Papillomavirus (HPV) vaccine, including recommendations for the bivalent HPV vaccine (Cervarix®) for females and the quadrivalent HPV vaccine (Gardasil®) for females and males.
These recommendations are reflected in the ACIP Provisional Recommendations for HPV Vaccine and will replace recommendations published in Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007; 56(No. RR-02).
Please Note: The bivalent HPV vaccine is now available for ordering by VFC Program providers.
Recommendations for Females
Two HPV vaccines are licensed for use to protect against common types of HPV that cause cervical cancers and precancers, and genital warts. The quadrivalent vaccine protects against HPV types 6, 11, 16, and 18, while the bivalent vaccine protects against HPV types 16 and 18. The ACIP recommends vaccination with either the bivalent or quadrivalent vaccine for prevention of cervical cancers and precancers. In addition, the quadrivalent HPV vaccine is recommended for prevention of genital warts and has been demonstrated to protect against vulvar and vaginal cancers and precancers.
Routine vaccination of females 11 and 12 years of age with 3 doses of HPV vaccine is recommended by the ACIP. The vaccination series can begin as early as 9 years of age. The VFC Program covers bivalent and quadrivalent HPV vaccine for eligible females age 9 through 18 years.
HPV vaccination also is recommended for females 13 through 26 years of age who have not been previously vaccinated or who have not completed the full vaccination series, regardless of prior potential exposure to HPV through sexual contact, since sexually active individuals may still benefit from vaccination.
Recommendations for Males
HPV can cause genital warts and penile and anal cancer in men. Males can also carry HPV, which can be transmitted to their sexual partners.
The 3-dose series of quadrivalent HPV vaccine may be given to males 9 through 26 years of age to reduce the risk of acquiring genital warts. The VFC Program resolution allows permissive use of quadrivalent HPV vaccine for VFC-eligible males, 9 through 18 years of age.
Recommendations for Administration, Precautions and Contraindications
- The quadrivalent and bivalent HPV vaccines are administered in a 3-dose schedule, with the second dose administered 1 to 2 months after the first dose, and the third dose 6 months after the first dose.
- The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum interval between the second and third dose of vaccine is 12 weeks. The minimum interval between the first and third dose is 24 weeks.
- If the HPV vaccine schedule is interrupted, the vaccine series does not need to be restarted.
- HPV vaccines are not live vaccines and can be administered either simultaneously or at any time before or after an inactivated or live vaccine.
- Whenever possible, the same HPV vaccine product should be used for all doses in the series.
- HPV vaccines are not recommended for use in pregnant women. However, pregnancy testing is not needed before vaccination. Any exposure to vaccine during pregnancy should be reported to the appropriate vaccine pregnancy registry:
- (800) 986-8999 (Merck and Co., Inc. for quadrivalent HPV vaccine)
- (888) 452-9622 (GlaxoSmithKline for bivalent HPV vaccine)
Vaccines for Children Resolution No. 010/09-1 - Human Papillomavirus Vaccine
December 11, 2009 -- The Bureau of Immunization is pleased to announce the release of Vaccines for Children (VFC) Program Resolution No. 010/09-1 for vaccines to prevent human papillomavirus (HPV). Resolution 6/08-2 is repealed and replaced. Resolution No. 010/09-1 was adopted and effective on October 21, 2009.
The purpose of Resolution 010/09-1 is to:
- Add bivalent HPV vaccine to the previous HPV VFC Program Resolution.
- Allow permissive use of the quadrivalent HPV vaccine for VFC-eligible males, 9 through 18 years of age.
- Streamline the resolution through the use of links to published documents.
Recommended dosage for the bivalent HPV vaccine can be found in the package insert available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186957.htm.
Recommended dosage for the quadrivalent HPV vaccine can be found in the package insert available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm.
The resolution is available online at www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/1009hpv-508.pdf.
Please Note: The bivalent HPV vaccine is now available for ordering by VFC Program providers.
Key Points Concerning Journal of the American Medical Association Human Papillomavirus Article
August 19, 2009 -- The Bureau of Immunization is pleased to share the following information from the Centers for Disease Control and Prevention (CDC). In anticipation of inquiries about Journal of the American Medical Association's (JAMA) August 19, 2009 release of Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine, the CDC has prepared a set of key messages for your use that summarize the study, explain the main findings, and give information on FDA and CDC actions moving forward. The CDC's website has additional information relating to the safety of the HPV vaccine.
Vaccine Safety Monitoring and Human Papillomavirus Vaccination
July 28, 2008 -- Human Papillomavirus (HPV) vaccine safety has recently been mentioned in both the national and state news. Please refer to the Centers for Disease Control and Prevention (CDC) website at www.cdc.gov/vaccines/vpd-vac/hpv/default.htm for additional information about the vaccine and the disease. The Department of Health, Bureau of Immunization provides the following summary points:
HPV Vaccination
- The CDC continues to recommend HPV vaccination because of its importance for the health of women. The CDC maintains this is a safe and effective vaccine. However, as with all vaccines, we will continue to review the safety of this vaccine and take appropriate action if there are issues with the vaccine. The risk of any vaccine causing serious harm, or death, is extremely small.
- Parents and providers are encouraged to report any adverse events to the Vaccine Adverse Event Reporting System (VAERS) vaers.hhs.gov (phone (800) 822-7967).
- Parents are encouraged to discuss HPV vaccination with their pre-teen’s doctor. The routine recommendation is to administer HPV vaccine at 11 and 12 years of age.
- The recommendation allows for vaccination to begin at 9 years of age.
- Vaccination also is recommended for females 13 through 26 years of age who have not been previously vaccinated or who have not completed the full series of shots.
- Syncope, or fainting, is a common event occurring with needle injections and vaccinations, especially in adolescents. CDC recommends that patients who receive HPV vaccine remain in the clinic for 15 minutes after vaccination to avoid potential injury from a fall.
HPV Disease
- HPV is a common virus. It is the major cause of cervical cancer in women.
- HPV infection usually occurs in people in their teens and early 20s.
- There are about 20 million people currently infected with HPV.
- Each year in the U.S., about 11,000 women will be diagnosed with cervical cancer, and 3,600 will die.
- Women have an 80% chance of developing HPV by the time they are 50.
- Because the vaccine is a preventative and not a cure, it is important that the vaccine be given prior to beginning sexual activity.
HPV disease and vaccine information is available at www.cdc.gov/vaccines/vpd-vac/hpv/, www.cdc.gov/cancer/cervical/basic_info, and www.cdc.gov/hpv/.
HPV Vaccine in the U.S.
- On June 8, 2006, the Food and Drug Administration (FDA) licensed the first vaccine (Gardasil®), developed to prevent cervical cancer and other diseases in females caused by certain types of genital HPV. The quadrivalent vaccine protects against four HPV types (6, 11, 16, and 18), which are responsible for 70% of cervical cancers and 90% of genital warts.
- On June 29, 2006, the Advisory Committee on Immunization Practices (ACIP) voted to recommend routine vaccination of females 11 and 12 years of age. Gardasil was tested in over 11,000 females (9 through 26 years of age) in many countries around the world, including the U.S. These studies found that the HPV vaccine was safe and caused no serious side effects. Adverse events were mainly injection site pain. This reaction was common but mild.
- Since licensure, more than 12 million doses of Gardasil vaccine have been distributed in the U.S. In 2006, a total of 2,151,000 doses were distributed, and in 2007, another 11,317,902. At this time, the U.S. does not have a national registry for immunization and vaccination, and therefore cannot report the total number of people who have received Gardasil.
- The number of serious adverse events reported to VAERS following HPV vaccine is less than seven percent of the total number of reports received. In comparison, the overall average in VAERS for any serious adverse event ranges from 10 to 15 percent; thus, the percentage of serious reports for Gardasil is less than the overall average.
Vaccine Safety Monitoring: VAERS
VAERS is part of a larger system that helps to ensure vaccines are safe and work as intended. VAERS is managed by the CDC and the FDA. To ensure vaccines are safe, vaccines are developed in accordance with the highest standards of safety. The FDA requires extensive safety testing before a vaccine is licensed and distributed to the public. After licensing, VAERS is used to continually monitor vaccines for safety and efficacy.
VAERS receives reports of many events that occur after immunization. Some of these events may occur coincidentally following vaccination, while others may truly be caused by vaccination. It is important to remember that many adverse events reported to VAERS may not be caused by vaccines. More indepth studies are usually required to investigate the association between a vaccine and an adverse event. Since 1990, most of the reported adverse events describe mild side effects, such as fever and rash. Through continued monitoring, VAERS helps to ensure that the benefits of vaccines are far greater than the risks. More information about VAERS can be found at www.cdc.gov/vaccinesafety/Activities/vaers.html.
Update to Immunization Schedules for Human Papillomavirus
April 4, 2008 -- The Florida Department of Health, Bureau of Immunization directs your attention to the Centers for Disease Control and Prevention (CDC), Morbidity and Mortality Weekly Report (MMWR) 2008; volume 57, number 12 on March 28, 2008. This MMWR contains an erratum on page 319 (Errata: Vol 57, No. 1) for the Recommended Immunization Schedules for Persons Aged 0--18 Years---United States, 2008.
Most important is the change/clarification to the intervals on the catch-up schedule for human papillomavirus (HPV) vaccine as follows:
On page Q-4, in the lower section of the Table titled, "Catch-up schedule for persons aged 7--18 years," in row "Human Papillomavirus", under column heading "Dose 2 to Dose 3", the text should read: "12 weeks (and 24 weeks after the first dose)." This change reflects addition of a 24-week minimum interval for the HPV series between dose 1 and dose 3. This means that the third dose needs to be administered no earlier than 6 months/24 weeks from the first dose. The minimum intervals between dose one and dose two, as well as between dose two and dose three, remain unchanged.
- Dose 1 to 2: 4 weeks
- Dose 2 to 3: 12 weeks (and 24 weeks after the first dose
The erratum may be viewed at www.cdc.gov/mmwr/preview/mmwrhtml/mm5712a6.htm.
The revised HPV interval was published on March 5, 2008 , and the correction to the human papillomavirus (HPV) vaccine regimen can be viewed on the CDC website at www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.
The MMWR may be viewed at www.cdc.gov/mmwr/preview/mmwrhtml/mm5701a8.htm.
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